CD16+ Monocytes in Coronary Heart Disease (CHD)

Coronary Heart Disease Clinical Trial

— PHAMOS  

Official title:

CD16+ Monocytes in Patients With Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442948
• Other study ID #: CD16PHAMOS
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: September 28, 2011
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The investigators hypothesize that the total numbers of CD16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• angiographically proven coronary heart disease

• Age > 18 years

Exclusion Criteria:

• life expectancy < 12 months

• inability to participate in the trial (to give written informed consent)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	University Clinic of the Martin Luther-University Halle-Wittenberg	Halle (Saale)	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint	Incidence of the combined endpoint (non-fatal myocardial infarction, cardiovascular death, stroke) during a follow-up of 12 months	12 months	No
Secondary	Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of each part of the combined endpoint + total death	non-fatal myocardial infarction; cardiovascular death; stroke; total death	12 months	No
Secondary	Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint	Subgroups of patients: Patients with stable Angina Patients with acute coronary syndrome	12 months	No